Methods and apparatus for regulating the flow of matter through body tubing

ABSTRACT

A self-retracting body, which may have a bore, may be inserted into a biological passage. A dilating balloon may be used to expand the body toward an inner wall of the passage. The body may include an anchor that may engage the wall. The anchor may include a tip that is within the body before the body expands and extends away from the body during expansion. The body may include an opening that may receive a portion of the wall. The portion may be fixed to the body. The body may retract toward a central portion of the passage after the anchor engages the wall. The wall may be drawn toward the central passage and the diameter of the passage may be reduced. In some embodiments, a liner may be provided for the passage. In some embodiments, a baffle may be provided for the passage.

This is a continuation of U.S. patent application Ser. No. 10/134,306,filed Apr. 26, 2002, which claims the benefit of U.S. Provisional PatentApplications Nos. 60/293,345, filed May 24, 2001, and 60/350,394, filedJan. 22, 2002, all of which are hereby incorporated by reference hereinin their entireties.

BACKGROUND OF THE INVENTION

The present disclosure concerns apparatus and methods for improving thefunction of biological passages. The ability of biological passages toexpand and contract actively or passively to regulate the flow ofsolids, liquids, gases, or combinations thereof, may be compromised bydefects or disease. One example of a condition associated with decreasedfunctionality of a body passage is Gastro Esophageal Reflux Disease(hereinafter, “GERD”), which effects the esophagus. Other body passagesthat may be subject to dysfunction, defect, and disease include, but arenot limited to, a fallopian tube, a urethra (for example, in the case ofincontinence), and a blood vessel (for example, in the case of ananeurysm). GERD and esophageal dysfunction will be further describedherein for the sake of illustration.

The normal healthy esophagus is a muscular tube that carries food fromthe mouth through the chest cavity and into the upper part of thestomach. A small-valved opening in the distal esophagus, called thelower esophageal sphincter (hereinafter, “LES”), regulates the passageof food into the stomach. When functioning properly, the LES musclepresents a barrier to the reflux of acid or food back into theesophagus. The LES also regulates the stomach intra-gastric pressures,regulating acidic gases from refluxing from the stomach back into theesophagus. The LES, when functioning properly, will open to allow gasesto be vented from the stomach. A healthy LES at rest can resist pressurefrom stomach gases that are at least 10 mm Hg greater than normalintragastric pressure. This pressure difference can regulate the amountof acidic fluid that refluxes from the stomach into the esophagus. TheLES is controlled largely by two components. The primary component isintrinsic smooth muscle of the distal esophagus wall. The secondcomponent is the skeletal muscle of the crural diaphragm or esophagealhiatus. The diaphragm is a muscle separating the stomach from the chest.Studies have shown that the diaphragm may act as a sphincter around thelower end of the esophagus. The esophageal hiatus is the opening in thediaphragm where the esophagus attaches to the stomach.

If the LES relaxes, atrophies, or degrades for any reason, the contentsof the stomach, which may be acidic, are allowed back into the esophagusresulting in reflux symptoms. The major mechanism for esophageal reflux,which may be associated with GERD, is the relaxation of one or both ofthe LES or hiatal diaphragm sphincter mechanisms. Normally occurringmechanisms that diminish or prevent GERD include peristaltic squeezingby the esophageal body, gravity (when a person is in an uprightposition), and neutralization by saliva.

Chronic or excessive acid reflux exposure may cause esophageal damage.Drugs may be required to manage symptoms of the damage and medicalintervention, including surgical or endoscopic procedures, may berequired to repair the damage.

The lining of the esophagus is called mucosa. Chronic exposure tostomach gases may cause the mucosa to become inflamed or ulcerated.Inflamed or ulcerated mucosa may lead to problems that may requiremedical intervention.

Hiatal hernias are often associated with GERD. If the esophageal herniabecomes enlarged (herniated), the LES function may be compromised andthe risk of GERD increased. (A hiatal hernia occurs when the upperpotion of the stomach moves up through an opening in the diaphragm.)

Barrett's Esophagus is a disease of the esophagus that may compromiseesophageal function. This disease may occur when the tissue thatordinarily lines the esophagus migrates away from the lower part of theesophagus to avoid exposure to the acidic fluids against the sensitivemucosa. Barrett's Esophagus is often a precursor to esophageal cancer.

The most common symptom of GERD is dyspepsia (commonly known as“heartburn”). Dyspepsia may be defined as an acute burning sensation inthe chest area typically, behind the sternum. Other symptoms of GERD mayinclude hemorrhage, pulmonary disorders, chronic cough, intermittentwheezing, ulcers, Barrett's esophagus, and esophageal cancer.

One conventional surgical treatment for GERD is fundoplication. In thisprocedure the upper part of the stomach is wrapped around the lower partof the esophagus. This highly invasive procedure is often initiallysuccessful, but has a high risk of morbidity (including, e.g., infectionand bleeding).

Another conventional treatment for GERD is surgical suturing of a pleatof tissue between the LES and stomach to make the lower esophagustighter. Suturing may be performed endoscopically using a suturingdevice on the end of an endoscope inserted into the esophagus throughthe mouth. Endoscopic procedures are less invasive than open surgery,but still require surgical incisions and great skill.

Surgery, whether endoscopic or open (such as fundoplication) may providea basic mechanical correction. Surgical procedures may relocate andaffix existing tissue of the stomach, esophagus, or both to add supportand structure to the LES. LES strength is increased by the addedsupport, thus reducing the incidence of reflux.

Yet another conventional treatment for GERD includes the use ofpharmaceutical drugs. The drugs may include acid blockers that mayreduce the production of acid by the stomach. The drugs may be effectiveto reduce the symptoms of mild GERD, but do not treat LES dysfunction.In general, the drugs must be administered indefinitely to maintaintheir efficacy.

Currently, according to the American Gastroenterological Association,over $12 billion is estimated to be spent on the treatment of GERDannually in the USA alone. It is estimated that $8 billion is spent ondrugs. According to a Gallup® poll, 45% of patients taking heartburndrugs report that current remedies do not relieve all symptoms and morethan half agree that they would try anything new to relieve theirheartburn.

Therefore, it would be desirable to provide improved apparatus andmethods for the treatment of a dysfunctional body passage.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and advantages of the invention will be moreapparent upon considering the following detailed description taken inconjunction with the accompanying drawings, in which like referencecharacters refer to like parts throughout, and in which:

FIG. 1 is a sectional view of an illustrative healthy biologicalpassage;

FIG. 2 is a sectional view of a defective biological passage;

FIG. 3 is a partial sectional view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 4 is an elevational view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 5 is an elevational view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 6 is an elevational view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 7 is an elevational view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 8 is a partial perspective view of apparatus in accordance with theprinciples of the invention in the biological passage shown in FIG. 2;

FIG. 9 is a partial perspective view of apparatus in accordance with theprinciples of the invention in the biological passage shown in FIG. 2;

FIG. 10 is a partial perspective view of apparatus in accordance withthe principles of the invention in the biological passage shown in FIG.2;

FIG. 11 is a partial perspective view of apparatus in accordance withthe principles of the invention in the biological passage shown in FIG.2;

FIG. 11A is a schematic view of apparatus in accordance with theprinciples of the invention in the biological passage shown in FIG. 2;

FIG. 11B is a schematic view of apparatus in accordance with theprinciples of the invention in the biological passage shown in FIG. 2;

FIG. 11C is a schematic view of apparatus in accordance with theprinciples of the invention in the biological passage shown in FIG. 2;

FIG. 11D is a schematic view of apparatus in accordance with theprinciples of the invention in the biological passage shown in FIG. 2;

FIG. 12 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 13 is a view taken from line 13-13 in FIG. 12 as it would appearafter the apparatus shown in FIG. 12 is formed into a closed loop;

FIG. 13A is a schematic view of apparatus in accordance with theprinciples of the invention;

FIG. 14 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 14A is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 15 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 15A is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 16 is a schematic view of apparatus in accordance with theprinciples of the invention;

FIG. 17 is a schematic view of apparatus in accordance with theprinciples of the invention;

FIG. 18 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 19 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the passage shown in FIG. 2;

FIG. 20 is a schematic view of an apparatus in accordance with theprinciples of the invention disposed in a biological passage;

FIG. 21 is a schematic view of an apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 22 is a sectional view of an apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 22A is a sectional view of the apparatus shown in FIG. 22, disposedin the biological passage shown in FIG. 20, in a different stage ofoperation;

FIG. 23 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 24 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 25 is a sectional view of an apparatus in accordance with theprinciples of the invention;

FIG. 26 is a partial sectional view of apparatus in accordance with theprinciples of the invention disposed in a portion of the biologicalpassage shown in FIG. 20;

FIG. 27 is a partial sectional view of apparatus in accordance with theprinciples of the invention disposed in a portion of the biologicalpassage shown in FIG. 20;

FIG. 28 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 29 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 30 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 31 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 32 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 33 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 34 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 35 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 36 is an elevational view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 37 is a partial sectional view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 38 is an elevational view of apparatus in accordance with theprinciples of the invention;

FIG. 39 is a sectional view of apparatus in accordance with theprinciples of the invention;

FIG. 40 is a perspective view of an apparatus in accordance with theprinciples of the invention;

FIG. 41 is a perspective view of an apparatus in accordance with theprinciples of the invention;

FIG. 42 is a perspective view of an apparatus in accordance with theprinciples of the invention;

FIG. 43 is a sectional view of apparatus in accordance with theprinciples of the invention;

FIG. 44 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 45 is a perspective view of an apparatus in accordance with theprinciples of the invention;

FIG. 46 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 47 is a top view of apparatus in accordance with the principles ofthe invention;

FIG. 48 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 49 is an elevational view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 50 is a partial elevational view of apparatus in accordance withthe principles of the invention disposed in the biological passage shownin FIG. 20;

FIG. 51 is a schematic view of apparatus in accordance with theprinciples of the invention;

FIG. 52 is an elevational view taken from line 52-52 of FIG. 51;

FIG. 53 is a sectional view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 54 is an elevational view taken from line 54-54 of FIG. 53;

FIG. 55 is a sectional view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 56 is a sectional view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 57 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 58 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 59 is a partial sectional view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 60 is a sectional view taken from line 60-60 in FIG. 59.

FIG. 61 is a partial sectional view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 62 is a partial elevational view of apparatus in accordance withthe principles of the invention disposed in the biological passage shownin FIG. 2;

FIG. 63 is a schematic view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 2;

FIG. 64 is a perspective view of an apparatus in accordance with theprinciples of the invention;

FIG. 65 is a perspective view of apparatus in accordance with theprinciples of the invention;

FIG. 66 is a partial top view of apparatus in accordance with theprinciples of the invention disposed in the biological passage shown inFIG. 20;

FIG. 67 is a partial elevational view taken from line 67-67 in FIG. 66;

FIG. 68 is a perspective view of an apparatus in accordance with theprinciples of the invention; and

FIG. 69 is a perspective view of an apparatus in accordance with theprinciples of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention may provide apparatus and methods for reducing thediameter or providing inwardly directed radial support to a portion of abiological passage. The invention may be used in a wide variety ofbiological passages including, but not limited to, passages that may bepresent in the alimentary canal, the digestive system, the respiratorysystem, the circulatory system, the reproductive system, and theexcretory system.

Some embodiments of the invention may include a body having a bore thatdefines a central axis. (The axis may follow an approximately centralpath through the body and in some embodiments may not be a straightline.) The central axis may define an axial, or longitudinal, direction.A plane perpendicular to or nearly perpendicular to the central axis maybe referred to herein as an axial plane. The body may be configured toexpand away from the axis. The body may be configured to contract towardthe axis.

At least one anchor may be coupled to the body. The anchor may beconfigured to engage a portion of the passage, for example, a portion ofa passage wall. The anchor may be configured to engage a portion of apassage inner wall. The body may be allowed to contract to pull the walltoward the axis. In some embodiments, the body may be a “reverse stent.”In some embodiments, the body may be a band.

In some embodiments, the body may include an elastic material. In someembodiments, the body may include a metal. In some embodiments, the bodymay include an alloy. In some embodiments, the body may include an inertmaterial. In some embodiments, the body may include a moldable material.As used herein, a material that is biocompatible and resistant toreaction with biochemical solids, liquids, and gases may be an inertmaterial. Stainless steel, nickel titanium alloy, tantalum and othernon-reactive metals may be inert. Polymers such as PTFE, polyurethane,polyamide, and those sold under the trademark PEBAX by Elf Atochem NorthAmerica may be inert. Medical grade metals and polymers may be inert.

The anchor may extend radially away from the axis. The anchor may extendin a non-radial direction away from the axis. The anchor may extend in acurved path away from the axis. The anchor may be pushed radiallyoutward into the inner wall. The anchor may be twisted or rotated aboutthe axis to engage the inner wall.

In some embodiments, the anchor may include an elastic material. In someembodiments, the anchor may include a metal. In some embodiments, theanchor may include an alloy. In some embodiments, the anchor may includea polymer. The anchor may include inert material. Some embodiments mayinclude one or more anchors having more than one of the foregoingfeatures. The anchor may be any suitable type of anchor, including anyof the anchors described herein.

In some embodiments of the invention, one or more anchors may be presentin or near an axial plane of the body. The axial plane may remainstationary or nearly stationary in the longitudinal direction when thebody is deformed in the radial direction. This feature may reduce stresson the passage wall near an anchor if the body deforms in connectionwith deployment in the passage. The feature may reduce stress on thepassage wall near the anchor if the body deforms in response todeformation of the biological passage. The biological passage may deformin response to muscular action, physiological processes, or any otherprocesses. For example, the passage may deform in response toperistalsis, circulatory pumping, excretory processes, reproductiveprocesses, or other physiological processes.

In some embodiments of the invention, the anchor may be shaped like adart. In some embodiments, the anchor may be include a “catch”. As usedherein, a catch is a feature of an anchor that may be used to resist thewithdrawal of the anchor from tissue. In some embodiments, a catch maybe used to pinch or pin tissue. In some embodiments, a catch may hookinto tissue (for example, as does a barb). In some embodiments, theanchor may include a staple. The staple may be C-shaped.

In some embodiments, the invention may include a sheath that may bedrawn over the body to protect the inner wall from the anchor, forexample, when the body is being inserted into the biological passage.The sheath may deflect the anchor away from a direction extendingradially away from the body axis. The sheath may be removed to engagethe anchor with the inner wall.

Some embodiments of the invention may include a lining. The lining maycover the entire surface of the body. The lining may cover a portion ofthe body. The lining may cover the anchor. In some embodiments, thelining may include an inert material.

Some embodiments of the invention may include a therapeutic substance.The substance may be present in or on the body. The substance may bepresent in the anchor, on the anchor, or both. The substance may bepresent in or on the lining. The substance may be embedded in a porousportion of the invention. The substance may elute from a portion of theinvention into the tissue of the biological passage. The substance mayinclude an agent configured to heal the tissue from a disease, defect,infection, inflammation, trauma, or any combination thereof. Thesubstance may include an agent configured to physically protect thetissue from acidic compounds. The substance may include an agentconfigured to chemically protect the tissue from acidic compounds. Forexample, the substance may act to neutralize an acidic compound. Thesubstance may be a drug. The substance may include a steroid. Thesubstance may include an antibiotic.

Some embodiments of the invention may include first and second crimpingmembers. The crimping members may be configured to apply force to theanchor to crimp the anchor to the inner wall of the biological passage.In some of these embodiments, the anchor may have prongs and be shapedlike a staple, a “C”, a “U”, or any other suitable form. The crimpingmembers may be used to bend the prongs to engage the biological passage.The crimping members may be used to secure the prongs to the biologicalpassage.

In embodiments of the body that include a moldable material, the anchormay be insert molded into a portion of the body. In some of theseembodiments, the anchor may be wholly or partially embedded in thepolymer. The anchor may be made from a material that is less elasticthan the polymer. When the body is expanded away from the axis, the bodyportion housing the anchor may become thinner in the radial dimension.As the body portion thins, the anchor may protrude through and extendradially beyond the portion. This feature may permit the device to beinserted into the passage with the anchor in a retracted position. Thefeature may permit the anchor to be exposed or “activated” automaticallyas the body is expanded. In embodiments having an anchor with a catch,this feature may permit the anchor to pinch a portion of the biologicalpassage inner wall against the body when the body contracts.

In some embodiments, the body may include portions having differentrelative flexibilities. Some portions may have high flexibility. Someportions may have low flexibility. One or more anchors may be coupled toa low flexibility portion. One or more anchors may be coupled to a highflexibility portion. When the body expands, contracts, or otherwisedeforms (for example, in response to peristalsis or other motion), thedeformation may be concentrated in the portions having high relativeflexibility. An anchor or anchors coupled to a low flexibility portionmay be subject to less stress, less displacement, or both than ifcoupled to a relatively high flexibility portion.

High flexibility portions may be, for example, thin, long, elastic,extensible, rotatable, or otherwise compliant. Low flexibility portionsmay be, for example, thick, short, inelastic, fixed against rotation orshorter, or otherwise noncompliant.

Portions having low flexibility may be referred to as “nodal” portions.Nodal portions may be coupled to high flexibility portions that may bereferred to as “transitional” portions. In some embodiments, the bodymay include a series of alternating nodal and transitional portionsarranged in a loop around the central axis. The longitudinal extensionof a portion (i.e., the extension in a direction parallel orapproximately parallel to the axis) may be referred to as an “axialspread.” In some of these embodiments, transitional portions may undergorotation to reduce the displacement of nodal portions when the body isdeformed.

In some embodiments, a node may be a portion of a relatively inflexibleband. The node may be joined to another node by a transition member thatbridges a gap between the nodes. The bridge member may include or beconfigured as a spring.

In some embodiments, the body may have the shape of a lobed strip. Thestrip may have a sinusoidal or wave-like form. The strip may form aclosed ring or band. In some embodiments, the strip may form a ring orband that is not completely closed. In some embodiments having lobes, alobe may be sutured to the biological passage.

In some embodiments, the body may include an opening that may receive aportion of the inner wall when the body contracts. As the body draws thepassage toward the axis, inner wall material may be forced into anincreasingly small volume and portion may intrude into the opening. Bothopen and closed cell bands (described below) and any other suitable typeof band, may have an opening through which inner wall tissue mayintrude. Some of these embodiments may include a fastener, a suture, orboth fasteners and sutures that may be used to secure the portion of thebody passage that intrudes through the opening. A clip may be attachedto intruded tissue within the lumen of the band to prevent the tissuefrom receding back through the opening. In some embodiments, the portionreceived by the openings may be permanently secured.

In some embodiments, the invention may include a catheter for insertingthe body into the biological passage.

In some embodiments, the body may be installed in the biological passageby placing the body in a portion of the passage, expanding the body,engaging the anchor or anchors with the passage inner wall, and allowingthe body to contract. In some embodiments, the body may be expanded andthe anchor or anchors secured in the inner wall using a balloon. In someembodiments, the body may be expanded sufficiently to partially engagethe anchor or anchors with the wall. In some of these embodiments, acrimping device may be used to complete the engagement of the anchor oranchors with the wall. In some embodiments, the crimping device may beused to secure the anchor or anchors in the wall without previouspartial engagement of the anchor or anchors.

In some embodiments, the body may be expanded without a balloon. Forexample, an expansion wedge may be passed through the bore. The wedgemay have an outside diameter greater than the inside diameter of thebore in a contracted state. The wedge may be tapered to facilitate entryinto the bore. The diameter of the wedge may be selected or adjusted toprovide a selected expansion of the body. In some of these embodiments,the minimum outward radial displacement of an anchor or anchors may beselected.

In some embodiments, the invention may include a liner for a portion ofthe biological passage. Some of those embodiments may include one ormore anchors to secure the liner to the biological passage. The linermay include a first plurality of anchors, a second plurality of anchors,and a sleeve. The sleeve may extend from the first plurality of anchorsto the second plurality of anchors. The sleeve may be configured toconform to the inner wall of the biological passage. The liner mayinclude a polymer such as PTFE, polyurethane, polyamide, and PEBAX®. Theliner may include any suitable medical polymer. The liner may includeany suitable material that does not readily react with biological fluidssuch as stomach acid, biological waste, or other materials that may bepresent in a biological passage.

In some embodiments, the invention may include a baffle for a portion ofa biological passage. The baffle may include a body that has an innerwall that defines a bore. The baffle may include at least one projectionor finger that extends from the inner wall into the bore. The bore maybe configured to be secured in the passage, for example, using an anchoror anchors. The finger may obstruct the flow of matter through thepassage. The finger may provide surface area that may promote biologicalor biochemical processes that neutralize or otherwise transformcompounds that may be undesirable or harmful to the passage or otherbiological entities. The baffle may include an inert material.

FIGS. 1 and 2 show esophageal anatomy. FIG. 1 shows healthy esophagus 2,including distal esophagus 3 connected to stomach 4. LES 6 is located atthe junction of esophagus 2 and stomach 4 where esophagus 2 passesthrough hiatus 8 in hiatal diaphragm 10. Sling fibers 12 in LES 6 aresmooth muscle tissue that may regulate distal esophagus 3. Hiatus 8 mayexternally support and regulate LES 6. LES 6 is normally open at rest.

FIG. 2 shows esophagus 22, which may be diseased, defective, orotherwise dysfunctional, including lumen 27 and distal esophagus 23connected to stomach 24. LES 26 is located at the junction of esophagus22 and stomach 24 where esophagus 22 passes through hiatus 28 in hiataldiaphragm 30, which may be diseased or defective. Sling fibers 32 in LES26 may be unable to regulate distal esophagus 23 and LES 26 may beunable to be closed or may be too easily opened. Hiatal diaphragm 30 maynot externally support esophagus 22 adjacent LES 26.

Illustrative examples of embodiments in accordance with the principlesof the present invention are shown in FIGS. 3-69.

FIG. 3 shows band 100, which may include one or more members such asmember 101, positioned in distal esophagus 23 above LES 26. Band 100 maybe installed in distal esophagus 23 to make it easier for LES 26 toclose. Band 100 may be supported by balloon 102, which may be at leastpartially inflated. Sheath 104 may be present around band 100 to deflectanchors (not shown) that may be coupled to the outside of band 100.Catheter 106 may be used to deliver or guide band 100, balloon 102, andshield 104 to distal esophagus 23. Balloon 102 may be positioned usingcatheter shaft 108.

FIG. 4 shows band 100 positioned in distal esophagus 23 above LES 26.Sheath 104 and catheter 106 (shown in FIG. 3) have been removed inpreparation for deployment of band 100. Band 100 may be supported byballoon 102, which may be inflated minimally to retain band 100. Balloon102 may be inflated to a more advanced degree to begin installing band100.

FIG. 5 shows band 100 in an advanced stage of deployment in distalesophagus 23. Balloon 102 is shown in an advanced stage of inflation toexpand band 100 into proximity with wall 25 of esophagus 22. An anchoror anchors (not shown), which may be coupled to band 100, may be pushedinto and engaged with wall 25 by the expansion of band 100. The anchoror anchors may be secured to wall 25 by crimping.

FIG. 6 shows band 100 in a state of contraction or partial contractionin distal esophagus 23 after balloon 102 has been removed. Balloon 102may be deflated or partially deflated before withdrawal from band 100 oresophagus 22. An anchor or anchors (not shown) that may secure band 100to wall 25 may reduce the diameter of distal esophagus 23 as band 100contracts. FIG. 6 shows that by reducing the diameter of distalesophagus 23, LES 26 may close.

FIG. 7 shows band 100 deployed in distal esophagus 23. LES 26 is in anopen state and may allow the passage of matter such as food F betweenesophagus 22 and stomach 24. The force with which band 100 contracts maybe selected (by selecting band flexibility, material properties, orboth, for example) to provide a selected degree of support to LES 26.The force may be selected to compensate for a particular degree ofdeficiency in LES 26 or hiatus 28. The force may be selected to allowLES 26 to open in response to a particular degree of muscular forcing,peristalsis, passage of matter along esophagus 22, reflux of matter fromstomach 24, or any combination thereof. The anchor or anchors may beaxially stationary or nearly axially stationary with respect to distalesophagus 23 when band 100 radially expands or radially contracts.

FIG. 8 shows band 200 which may support anchor 206. Anchor 206 mayengage distal esophagus 23. Band 200 may support more than one anchorhaving the features of anchor 206. Band 200 may include one or morelobes such as lobe 290. Lobe 290 may include one or more curved portionssuch as curved portion 280. Curved portion 280 may support one or moreanchors. Anchor 206, which may include one or more barbs such as barb208, may be maintained in a retracted state by delivery sheath 204.Balloon 202 may be at least partially inflated to retain and/or positionband 200. The position of balloon 202 may be controlled by cathetershaft 295.

FIG. 9 shows band 200 positioned in distal esophagus 23. Balloon 202 isin an at least partially expanded state. Anchor 206 is in contact withwall 25 of distal esophagus 23. Delivery sheath 204 is withdrawn in aproximal direction from band 200 allowing anchor 206 to relax to adirection facing wall 25. (As used herein, the proximal direction istoward the point of entry of the apparatus into the biological passage.The distal direction is opposite the proximal direction. In thisexample, the point of entry may be the mouth.)

FIG. 10 shows that balloon 202 may be further expanded to drive anchor206 into the tissue of distal esophagus 23. Barb 208 may engage anchor206 with distal esophagus 23. Head 214 of anchor 206 may be positionedthroughout the thickness of distal esophagus 23. In some embodiments,head 214 may emerge through outer wall 236 of distal esophagus 23.

FIG. 11 shows balloon 202 in a deflated or partially deflated state.Balloon 202 may be withdrawn from band 200 to allow band 200 to retracttoward central region 34 of distal esophagus 23. Anchors such as anchor206 secured to distal esophagus 23 may draw wall 25 toward centralregion 34. When wall 25 is drawn toward central region 34, LES 26 may besufficiently supported to achieve the closed state shown in FIG. 11.

FIGS. 11A-11D show an illustrative embodiment of the invention in stagesof deployment in distal esophagus 23 that correspond to the stages shownin FIGS. 8-11 in connection with band 200 and apparatus associatedtherewith. FIG. 11A shows band 1100 which may include an anchor oranchors such as anchors 1106 and 1107 for engagement with distalesophagus 23. Band 1100 may include one or more lobes such as lobe 1190.In some embodiments, lobe 1190 may not have a curved portion such ascurved portion 280 (shown in FIG. 8). Lobe 1190 may support one or moreanchors. Anchors 1106 and 1107, which may include one or more barbs suchas barb 1108, may be maintained in a retracted state by delivery sheath1104.

In some embodiments, a retracted anchor may extend in the distaldirection as does anchor 1106. In some embodiments, a retracted anchormay extend in the proximal direction as does anchor 1107. In someembodiments, a retracted anchor may extend in the radial direction (notshown). Balloon 1102 may be partially inflated to retain and positionband 1100. The position of balloon 1102 may be controlled by cathetershaft 1108.

FIG. 11B shows band 1100 positioned in distal esophagus 23. Balloon 1102may be at least partially expanded. Delivery sheath 1104 may bewithdrawn in a proximal direction from band 1100 allowing anchors 1106and 1107 to relax to a direction facing wall 25. One or both of anchors1106 and 1107 may contact wall 25 of distal esophagus 23.

FIG. 11C shows that balloon 1102 may be further expanded to drive one orboth of anchors 1106 and 1107 into distal esophagus 23. Barbs 1108 mayengage one or both of anchors 1106 and 1107 with the tissue of distalesophagus 23. Heads 1114 and 1115 of anchors 1106 and 1107,respectively, may be positioned throughout the thickness of distalesophagus 23. In some embodiments, one or both of heads 1114 and 1115may extend through the outer wall of distal esophagus 23.

FIG. 11D shows balloon 1102 in a deflated or partially deflated state.Balloon 1102 may be withdrawn from band 1100 to allow band 1100 toretract toward central region 34 of distal esophagus 23. Anchors such asanchors 1106 and 1107 secured to distal esophagus 23 may draw wall 25toward central region 34. Anchors 1106 and 1107 may pull in a portion ofwall 25 that extends at least along region 1140. When wall 25 is drawntoward central region 34, LES 26 may be sufficiently supported toachieve the closed state shown in FIG. 11.

FIGS. 12-17 show illustrative examples of bands. FIG. 12 showsillustrative apparatus 1200 in unrolled form for the sake ofillustration. In use, ends A and B may be joined to form a continuousband 1200 into a continuous undulating loop. Apparatus 1200 may includeband 1202. In some embodiments, band 1202 may be formed from a tube, inwhich case ends A and B may be part of a continuous piece of material.Apparatus 1200 may include one or more anchors such as 1210. Anchor 1210may include one or more barbs such as barb 1212. Band 1200 may includeone or more upper lobes such as upper lobe 1208. Band 1202 may includeone or more lower lobes such as lower lobe 1218.

In some embodiments, anchor 1210 may be present on or near medial axialplane MAP. Plane MAP may be on or near the longitudinal center ofapparatus 1200. In some embodiments, one or more anchors may be presenton band 1202 not on or near plane MAP. In some of those embodiments, oneor more anchors may be present on the lobes. (Although plane MAP isshown in connection with apparatus 1200, plane MAP may be shown inconnection with other embodiments of the invention to illustrate aspectsof those embodiments that may correspond to aspects of apparatus 1200.)

Lower lobe 1218 and upper lobe 1208 may be open in directions Y and X,respectively. The presence of open lobes is a feature that may bereferred to as “open cell” design. The number of upper and lower lobespresent between ends A and B may be less than or greater than the numbershown. Lower lobe 1218 may be coupled to upper lobe 1208 by a connectingportion such as connecting portion 1228. In some embodiments, one ormore anchors may be present on one or more connecting portions.

FIG. 13 schematically shows illustrative band apparatus 1200 viewed fromline 13-13 in FIG. 12, but with ends A and B joined together.Longitudinal or nearly longitudinal directions X and Y are shown in FIG.12 in connection with apparatus 1200. Axis C and directions R, I, P, andQ are shown in FIG. 13 in connection with apparatus 1200. For the sakeof simplicity, the axis and the directions will be used to illustrateaspects of other embodiments of the invention that may correspond toaspects of apparatus 1200. Direction R is a direction that extendsradially outward from axis C. Direction I is a direction that extendsradially inward toward axis C. In some embodiments, axis C may not be inthe exact center of a band. In some embodiments, direction R may be anapproximately radially outward direction. In some embodiments, I may bean approximately radially inward direction. For the sake of clarity,direction I may be shown separate from direction R.

Similarly, ends A and B will be used to illustrate aspects of otherembodiments of the invention that may correspond to aspects of apparatus1200.

Central axis C passes through bore 1230 of band 1202. In someembodiments, anchor 1210 may extend in a direction that has componentsparallel to axis C and radial direction R. In some embodiments, anchor1210 may extend in a direction that is extends in (or nearly in) radialdirection R.

Band 1202 may be expanded in direction R to engage anchors 1210 and 1220with biological tissue of a biological passage. When band 1202 expandsin direction R, it may also expand in directions P. When band 1202expands in directions P, upper lobes such as lobe 1208 may move fartherapart from each other, lower lobes such as lobe 1218 may move fartherapart from each other, and connecting portions such as portion 1228 maymove farther apart from each other. During the expansion of band 1200,upper lobe 1208 and lower lobe 1218 may move in directions X and Y(shown in FIG. 12), respectively. During expansion of band 1202, planeMAP, and any anchor or anchors positioned in or near plane MAP, may bestationary or nearly stationary with respect to the biological passagein which apparatus 1200 is deployed.

One or more of anchors 1210 and 1220 may engage biological tissue. Band1202 may be allowed to contract in direction I to draw the tissue towardaxis C. (Direction I is the opposite of radial direction R, but is shownseparately from direction R for the sake of clarity.) Duringcontraction, upper lobes such as lobe 1208 may move closer to eachother, lower lobes such as lobe 1218 may move closer to each other, andconnecting portions such as portion 1228 may move closer to each other.During contraction of band 1202, plane MAP, and any anchor or anchorspositioned in or near plane MAP, may be stationary or nearly stationarywith respect to the biological passage in which apparatus 1200 isdeployed. Barb 1212 may secure tissue to anchor 1210 during contraction.Barb 1212 may continue to secure tissue to anchors 1210 aftercontraction is complete.

FIG. 13A shows illustrative apparatus 1300 in unrolled form for the sakeof illustration. Apparatus 1300 may include band 1302. In use, ends Aand B may be joined to form band 1302 into a continuous undulating loop.Band 1302 may include one or more upper lobes such as lobe 1308. Band1302 may include one or more lower lobes such as lobe 1318. One or moreupper anchors such as anchor 1390 may be present on upper lobe 1308. Oneor more lower anchors such as anchor 1392 may be present on lower lobe1318. In some embodiments, during expansion, upper anchor 1390 and loweranchor 1392 may move in directions X and Y, respectively. In embodimentsin which anchors 1390 and 1392 extend in a direction having componentsparallel to both C and R, the opposing movement of the anchors 1390 and1392 may help anchors 1390 and 1392 engage biological tissue disposedbetween them.

FIG. 14 shows illustrative open cell apparatus 1400 unrolled for thepurpose of illustration. Apparatus 1400 may include band 1402. Band 1402may include one or more upper lobes such as upper lobe 1408. Band 1402may include one or more lower lobes such as lower lobe 1418. One or moreanchors such as anchor 1410 may be present on band 1402. Anchor 1410 maybe present on or near medial axial plane MAP. In some embodiments, band1402 may have more lobes than are shown in FIG. 14. In some embodiments,band 1402 may have fewer lobes than are shown in FIG. 14. Double barbs1412 may be present on anchor 1410. Some embodiments may include one ormore anchors that include more than or less than two barbs.

FIG. 14A shows illustrative open cell apparatus 1400′ unrolled for thepurpose of illustration. Apparatus 1400′ may include band 1402′. Band1402′ may include one or more upper lobes such as upper lobe 1408′. Band1402′ may include one or more lower lobes such as lower lobe 1418′. Oneor more upper anchors such as upper anchor 1450 may be present on upperlobe 1408′. One or more lower anchors such as lower anchor 1460 may bepresent on lower lobe 1418′. In some embodiments, one or both of anchors1450 and 1460 may not be present on medial axial plane MAP. In someembodiments, band 1402′ may have more lobes than are shown in FIG. 14.In some embodiments, band 1402′ may have fewer lobes than are shown inFIG. 14. Double barbs 1412′ may be present on one or both of anchors1450 and 1460. Some embodiments may include one or more anchors thatinclude more than or less than two barbs.

FIG. 15 shows illustrative open cell apparatus that may include band1502. Band 1502 is shown unrolled between ends A and B. Lobes such asupper lobe 1508 may include a rigid portion such as portion 1550. Lobessuch as lower lobe 1518 may include a rigid portion such as portion1560. One or more anchors such as anchors 1510 may be present on rigidportion 1550. One or more anchors such as anchors 1520 may be present onrigid portion 1560.

During expansion, flexible portions 1554 and 1556 may deform to allowconnecting member 1528 to rotate in direction J. The deformation ofportions 1554 and 1556 may allow lobes 1508 and 1518 to move away fromeach other along directions P and Q, respectively, without causing rigidportions 1550 and 1560 to migrate toward each other in directions X andY (shown also in FIG. 12), respectively. The deformation of portions1554 and 1556 may allow lobes 1508 and 1518 to move away from each otheralong directions P and Q, respectively, without causing anchors 1510 and1520 to migrate toward each other in directions X and Y (shown also inFIG. 12), respectively.

During contraction, flexible portions 1554 and 1556 may deform to allowconnecting member 1528 to rotate in direction K. The deformation ofportions 1554 and 1556 may allow lobes 1508 and 1518 to move toward eachother along directions Q and P, respectively, without causing rigidportions 1550 and 1560 to migrate away from each other in directions Yand X (shown also in FIG. 12), respectively. The deformation of portions1554 and 1556 may allow lobes 1508 and 1518 to move toward each otheralong directions Q and P, respectively, without causing anchors 1510 and1520 to migrate toward each other in directions Y and X (shown also inFIG. 12), respectively.

FIG. 15 shows rigid portions 1550 and 1560 shaped and sized to make themmore rigid than flexible portions 1554 and 1556. Some embodiments of theinvention may include rigid portions that are made of less pliantmaterial than flexible portions 1554 and 1556. In some of thoseembodiments, rigid portions 1550 and 1560 and flexible portions 1554 and1556 may have equivalent shapes or dimensions. For example, if a rigidportion includes material that is less elastic than a flexible portion,dimensions such as cross sections M and N shown in FIG. 15 for rigidportion 1550 and flexible portion 1554, respectively, may be madeapproximately the same. In some embodiments, rigid portions 1550 may bereferred to as “nodes.”

Any suitable mechanism for allowing a connecting member such as 1528 toreduce movement in directions X and Y when band 1502 expands orcontracts may be used. For example, a connecting member may be aflexible coil coupled to rigid members 1550 and 1560. When band 1502expands, the coil may expand. When band 1502 contracts, the coil maycontract. Some embodiments of the invention may include a connectingmember that has reciprocating elements that may cause the connectingmember to lengthen or shorten in response to band expansion andcontraction, respectively. In some embodiments, connecting members 1528may be referred to as “transition” members.

FIG. 15A shows apparatus 1500′ that, in some embodiments, may be similarto apparatus 1500 (shown in FIG. 15) with the exception of thearrangement of anchors. Some or all of upper anchors 1510′ may bepresent on band 1502′ in or near axial plane AP1. Some or all of loweranchors 1520′ may be present on band 1502′ in or near axial plane AP2.Axial planes AP1 and AP2 may be positioned at any suitable axialpositions.

FIG. 16 shows illustrative band 1600 unrolled between ends A and B. Band1600 may include one or more upper lobes such as upper lobe 1608. Band1600 may include one or more lower lobes such as lower lobe 1618. One ormore anchors such as anchor 1610 may be present on upper lobe 1608. Oneor more anchors such as anchor 1620 may be present on lower lobe 1618.Upper lobe 1608 may be directly opposite lower lobe 1618 to form aclosed “cell” such as closed cell 1650. Closed cell 1650 may includeopening 1660. The presence of closed cells is a feature that may bereferred to as “closed cell” design. Any suitable number of closed cellsmay be present in band 1600.

FIG. 17 shows band 1600 in an expanded state. Band 1600 has beenradially expanded (in direction R as shown in FIG. 12). Axial spreadL_(E) of band 1600 in the expanded state is less than axial spread L_(N)(shown in FIG. 16) of band 16 in the normal state.

FIG. 18 shows one of closed cells 1650 as viewed from line 18-18 in FIG.17. Closed cell 1650 may include upper lobe 1608 and lower lobe 1618.One or more anchors such as anchor 1610 may be present on upper lobe1608. One or more anchors such as anchor 1620 may be present on lowerlobe 1618. One or more anchors on closed cell 1650 may extend away fromaxis C in a direction that has a component parallel to the direction R(also shown in FIG. 12). One or more anchors on closed cell 1650 mayextend away from axis C in a direction that has a component parallel toaxis C.

FIG. 19 shows (schematically) illustrative open cell device 1900deployed in distal esophagus 23 above LES 26. Anchors 1910, which mayinclude barbs 1912, are engaged with distal esophagus 23. Any suitablenumber of anchors 1910 may be present on device 1900. Any suitable typeor types of anchors may be present on band 1900. Anchors may be locatedon any suitable portion of device 1900.

FIGS. 20-23 show illustrative examples of the placement of anchorsaccordance with the principles of the invention. FIG. 20 shows anchor2010 present in biological tubing 2020 passing through body cavity 2030.Anchor 2010 may be referred to as a “dart.” Anchor 2010 may include stem2011 in lumen 2022 and head 2014 embedded in wall 2028. Base 2006 may beattached to apparatus for reducing the diameter of tubing 2020. One ormore barbs such as 2012 may secure head 2014 in the tissue of wall 2028.Head 2014 may be embedded anywhere along thickness T of wall 2028.

In some embodiments, head 2014 may be positioned in wall 2028 near innerface 2032 to avoid applying stress to the portion of wall 2028 nearouter surface 2036 when anchor 2110 is drawn toward lumen 2022. In someembodiments, head 2014 may be positioned in wall 2028 near outer surface2036 to enable head 2014 to be supported by a large portion of thetissue of wall 2028 when anchor 2110 is drawn toward lumen 2022.

FIG. 21 shows anchor 2110 partially present in tubing 2020 that may bepresent in body cavity 2030. Anchor 2110 may include stem 2111 passingthrough wall 2028 and head 2114 that may be present in cavity 2030. Head2114 may have been pushed through wall 2028 into cavity 2030. One ormore barbs such as 2112 may engage outer wall 2036 of tubing 2020 toprevent anchor 2110 from withdrawing from wall 2028 and passing backtoward lumen 2022. Base 2106 may be coupled to apparatus for reducingthe diameter of tubing 2020. Base 2106 may be coupled to apparatus forreducing the diameter of lumen 2022.

FIG. 22 shows anchor 2210 present in tubing 2020 passing through bodycavity 2030. Anchor 2210, which may at least partially pass through wall2028, may include stem 2211 and head 2214. Head 2214 may includeflexible portion 2216. Flexible portion 2216, which may be a skivedportion, may rest against anchor surface 2218 when head 2214 is presentin wall 2028. In some embodiments, surface 2220 of flexible portion 2216may align flush or nearly flush with surface 2222 of stem 2211. Interiorportion 2224 may be coupled to apparatus for reducing the diameter oflumen 2022.

FIG. 22A shows anchor 2210 at a later stage of insertion in wall 2028than that shown in FIG. 22. Head 2214 may have advanced through outerface 2036 of wall 2028 and be at least partially disposed in body cavity2030. Flexible portion 2216, which may be biased away from surface 2218,may move away from surface 2218 of stem 2211. Tip 2226 may move awayfrom stem 2211. Tip 2226 may engage surface 2036 to prevent anchor 2210from moving toward lumen 2022. Surface 2228 may separate from surface2218. Surface 2228 may engage or partially engage surface 2036 toprevent anchor 2210 from moving toward lumen 2022.

FIGS. 23-34 show features of some embodiments of the invention that mayinvolve attaching a band to biological tubing using crimping technology.FIG. 23 shows open cell device 2300 present in lumen 2022 of biologicaltubing 2020. Device 2300 may be expanded outwardly away from axis C inradial direction R. Device 2300 may be contracted toward axis C inradial direction I. Device 2300 may include on or more crimpable anchorssuch as anchor 2310, which may have prongs 2330. In some embodiments ofthe invention, a crimpable anchor may be a staple. Anchor 2310 may beC-shaped. Anchor 2310 may be U-shaped. Anchor 2310 may be used inconjunction with one or more dart anchors. Anchor 2310 may include oneor more barbs such as barb 2320 for engaging tissue. FIG. 23 showsanchors 2310 positioned near (or in contact with) inner face 2032 ofwall 2028.

FIG. 24 shows device 2300 expanded in direction R relative to the stateshown in FIG. 23. Prongs 2330 have at least partially penetrated throughinner face 2032 into the tissue of wall 2028. One of prongs 2330 isshown to have penetrated wall 2028 to depth H. In some embodiments, themaximum value of H may be limited by the shape of anchor 2310. In someembodiments, the maximum value of H may be limited by the length ofprongs 2330. Barbs 2320 may prevent prongs 2330 from pulling out of wall2028 when band 2300 is allowed to contract along inner radial directionI toward axis C.

FIG. 25 shows open anchor 2310 which may have maximum penetration depthZ. Anchor 2310 may have one or more sharpened points such as 2340.Anchor 2310 may have one or more sharpened edges such as 2350. Anchor2310 may have one or more barbs such as 2320.

FIG. 26 shows illustrative crimping tool 2600 which may be used to crimpanchor 2310. Tool 2600 may be inserted into lumen 2022. Elongatedportion 2620 may be extended distally past a portion of device 2300 tosupport crimping member 2680. Crimping member 2670 may be positionedproximally of a portion of device 2300. Crimping members 2670 and 2680may be drawn together in directions D against prongs 2330 of anchor2310. Crimping members 2670 and 2680 may force sharp points 2340 intotissue of wall 2028. Sharp edges 2350 may cut tissue of wall 2028 asprongs 2330 penetrate.

FIG. 27 shows anchor 2310 secured in the tissue of wall 2028 aftercrimping by tool 2600. Prongs 2330 are at least partially inserted inwall 2028. Prongs 2330 may be held in place by barbs 2320. Prongs 2330may be held in place by the closure of anchor 2310 by tool 2600. Sharppoints 2340 may be drawn toward each other as anchor 2310 is closed.Device 2300 in lumen 2022 may be used to pull wall 2028 toward thecentral portion of lumen 2022.

FIGS. 28 and 29 show illustrative embodiments of crimpable anchors. FIG.28 shows device 2800 in lumen 2022. Device 2800 may include band 2802.Band 2802 may include crimpable anchor 2810. Anchor 2810 may have one ormore prongs such as 2830. Prong 2830 may have one or more elongatedmembers such as 2812 and 2814. Elongated members 2812 and 2814 may becoupled at angled junction 2816. One or more barbs such as barb 2820 maybe present on prong 2830 to engage tissue of wall 2028. Barbs 2820extend away from interior region 2840 of anchor 2810. In someembodiments, one or more barbs may extend toward the central portion oflumen 2022. In some embodiments, both internally directed and externallydirected (i.e., away from region 2840) barbs may be present.

FIG. 29 shows device 2900 in lumen 2022. Device 2900 may include band2902. Device 2900 may include crimpable anchor 2910. Anchor 2910 mayhave one or more curved prongs such as 2930. One or more barbs such asbarb 2920 may be present on prong 2930 to engage tissue of wall 2028.Barbs 2820 extend away from interior region 2940 of anchor 2910. In someembodiments, one or more barbs may extend toward interior region 2940.In some embodiments, both internally directed and externally directedbarbs may be present.

FIG. 30 shows band 2802 in lumen 2022 expanded away from axis C indirection R. Band 2800 may be expanded by dilation of a balloon (notshown). Anchors 2810 may be crimped, for example using tool 2600, intoportions of wall 2028. FIG. 31 shows wall 2028 drawn in direction Itoward axis C by band 2800 after band 2802 is allowed to contract. Barbs2820 may prevent anchors 2810 from pulling out of wall 2028. FIG. 32shows band 2802 deployed below and supporting LES 26 in esophagus 22above stomach 24.

FIGS. 33-35 illustrate embodiments of the invention that may includeballoon-actuated anchor crimping. Although illustrated in relation toopen cell device 3300 and anchor 3310, any suitable type of band and anysuitable type of anchor or anchors, including band types and anchortypes described and illustrated herein, may be used for balloon-actuatedcrimping. FIG. 33 shows device 3300 in lumen 2022. Device 3300 mayinclude band 3302. Device 3300 may include one or more crimpable anchorssuch as anchor 3310. For clarity, only two anchors are shown in FIG. 33,but other anchors may be present in device 3300. Anchor 3310 may includesharp points 3340 for penetrating wall 2028. Balloon 3302 may beneutrally inflated within device 3300, for example, with sufficientpressure to retain device 3300 and position band 3302 at a selectedlocation in lumen 2202.

FIG. 34 shows that in some embodiments of the invention, balloon 3390may be dilated within band 3302 to drive anchors 3310 into wall 2028. Insome of those embodiments, balloon 3390 may drive anchor 3310 into wall2028 when the pressure inside balloon 3390 is about 10 atmospheres abovethe ambient pressure in lumen 2202. In some embodiments, dilationsufficient to cause sharp points 3340 to penetrate wall 2028 may be afirst stage of dilation of balloon 3390.

FIG. 35 shows that balloon 3390 may be dilated to a state greater thanthat shown in FIG. 34. This stage may be a second dilation stage. In thesecond dilation stage, anchor 3310 may be crimped by balloon 3390 tosecure anchors 3310 in wall 2028. In the second dilation stage, balloon3390 may have an internal pressure about 20 atmospheres greater than thepressure external to balloon 3390 in lumen 2022.

Balloon 3390 may include regions of variable compliance. For example,central region 3304 of balloon 3390 may have a first compliance,proximal region 3306 may have a second compliance, and distal region3308 may have a third compliance. In some embodiments, regions 3306 and3308 may have approximately the same compliance. In some of thoseembodiments, region 3304 may have a compliance that is less than thecompliance of regions 3306 and 3308.

In some embodiments, balloon 3390 may include central region 3304 havinga compliance greater than the compliance of regions 3306 and 3308. Inthose embodiments, as balloon 3390 is dilated in the second dilationstage, regions 3306 and 3308 may expand more than central region 3304.Some embodiments may include balloon portions 3380, which may be nearthe transitions between regions of different compliances. Portions 3380may apply force to anchor 3310 to crimp anchor 3310 into a secureconfiguration. Anchor 3310 may be permanently secured, or locked, intowall 2028.

In some embodiments, the force applied by portions 3380 may have acomponent that is parallel to the axial direction of lumen 2022. Theaxial force component may cause anchor 3310 to close. FIG. 35 showssharp points 3340 of anchor 3310 in close proximity to each other.

In some embodiments, balloon 3390 may have a uniform compliance. In someof those embodiments, anchor 3310 may be crimped by balloon dilation.For example, the size of band 3302 may be chosen so that when band 3302is maximally expanded, anchor 3310 is partially engaged in wall 2028. Asballoon 3390 continues to dilate, regions 3380 may expand “around” andapply an axial crimping force to anchor 3310 as described above.

In some embodiments of the invention, band 3302 may have compoundcompliance. A first compliance may dominate when band 3302 is expandedtoward wall 2028 and when anchor 3310 is partially engaged in wall 2028.A second compliance may dominate when anchor 3310 are crimped. Thesecond compliance may be less than the first compliance to “bind”balloon 3390 to cause portions 3380 to generate axial forces on anchors3310.

In some embodiments, anchor 3310 may be self-crimping. For example,balloon 3390, which in self-crimping embodiments may have compound oruniform compliance, may push anchor 3310 radially away from the centerof lumen 2022 into wall 2028. The curvature of prongs 3330 (or, in thecase of angled prongs like 2830, the angle of the prongs) may beselected to cause anchor 3310 to close in response to being radiallydriven into wall 2028.

FIGS. 36-38 show features of embodiments of the invention that mayinvolve clipping, pinning, suturing, or otherwise fastening a band to aninner wall of a portion of biological tubing. FIG. 36 shows band 3600positioned in lower esophagus 23 above LES 26 and stomach 24. Tissue3602 from wall 25 of esophagus 22 may be present in or emerging fromopenings 3620 in band 3600. (In FIG. 36, wall 25 is shown spanningesophagus 22 from left to right behind band 3600. Only the portion ofband 3600 adjacent that portion of the wall is shown in FIG. 36.) Clips3650 may be attached to portions of tissue 3602 to prevent the portionsfrom receding back through the holes. Clips 3650 are shown havingvertices 3660 positioned distally with respect to open ends 3670, butany suitable orientation of clips 3650 may be used. In some embodiments,tissue 3620 may be pinned or sutured to band 3600, or may be made secureby any combination of methods, which may include clipping.

In some embodiments of the invention, tissue 3602 may intrude throughopenings 3620 after band 3600 is attached to wall 25 using anchors (notshown). Band 3600 may be allowed to contract toward the central regionof esophagus 22 and tissue 3602 may be forced through openings 3620 whenthe diameter of wall 25 is reduced by the pulling-in action of band3600. Band 3600 is a type of closed cell band. Although a closed cellband is used to illustrate the clipping feature of some embodiments ofthe invention, the clipping feature may be present in embodiments of theinvention involving any suitable type of band.

FIG. 37 shows tissue 3620 from wall 25 of esophagus 22 compressedthrough an opening in band 3600. Tissue 3620 may be held in place in thelumen of esophagus 22 (in the interior of band 3600) by clip 3650 whichmay include vertex 3660 and open end 3670. Clip 3650 may be made fromspring metal, ductile metal, polymer, or any other suitable material.Clip 3650 may include one or more barbs to secure clip 3650 to tissue3620. Although clip 3650 is a “V”-clip, any suitable form of clip may beused.

FIG. 38 shows clip 3650 seated in clip fastening device 3800. Stem 3830may be inserted in biological tubing in which a band is to be secured.Clip 3650 seated between arms 3820 may be positioned around a portion oftissue to be secured (such as tissue 3620 shown in FIG. 37). Arms 3820may be rotated about pins 3840. Arms 3820 may be actuated by one or moreactuating members (not shown) present in or near stem 3830. In someembodiments, one arm may be fixed and the other arm may be actuated.Arms 3820 may be drawn together to compress clip 3650 into tissue 3620(shown in FIG. 37). Device 3800 may be withdrawn from esophagus 22 toleave clip 3650 secured to tissue 3620.

FIG. 39 shows illustrative apparatus 3900 that may be used to reduce thediameter of a portion of biological tubing. In some embodiments of theinvention, one or more apparatus such as apparatus 3900 may be deployedin a biological passage. In those embodiments, apparatus of differentsizes or elastic properties may be used to provide different amounts ofsupport to different parts of the passage. Apparatus 3900 may have aneutral state having a neutral diameter. Apparatus 3900 may becompressed to a state in which the diameter is less than that in theneutral state to facilitate the insertion of apparatus 3900 in a portionof body tubing. Apparatus 3900 may by expandable radially away from axisC to an expanded state. From the expanded state, apparatus 3900 mayautomatically retract toward the neutral state. In some embodiments,apparatus 3900 may include an elastic material. In some of thoseembodiments, apparatus 3900 may include a polymer.

Apparatus 3900 may be inserted in a portion of tubing and expanded indirection R away from central axis C to engage one or more anchors suchas anchor 3910 in the tubing wall. Anchor head 3914 may penetrate thewall. Apparatus 3900 may then be allowed to contract in direction Itoward axis C. The contraction of apparatus 3900 may pull the tubingwall toward axis C and reduce the diameter of the tubing. Edge (or“catch”) 3912 may engage wall tissue and prevent anchor 3914 fromwithdrawing from the wall during the contraction. Edge 3912 may preventanchor 3914 from withdrawing from the wall after contraction.

Anchor 3910 may have one or more anchor heads such as head 3914. Anchorhead 3914 may be coupled to stem 3920. In some embodiments, stem 3920may extend radially away from axis C. In some embodiments, stem 3920 mayextend away from axis C in a direction that has a non-radial component.In some of those embodiments, numerous stems curving away from band 3902may be present to permit apparatus 3900 to be installed in the wall byrotating apparatus 3900 about axis C. For example, stem 3920 may curveaway from band 3902 in an axial plane. In some embodiments, stem 3920may extend away from band 3902 in a direction that is oblique withrespect to both axis C and radial direction R. In some embodiments, stem3920 may curve away from band 3902 in directions that are oblique withrespect to both axis C and radial direction R.

Stem 3920 may be coupled to base 3930. Base 3930 may be embedded in band3902 of apparatus 3900. In some embodiments, band 3902 may be formedfrom a moldable material such as a flexible polymer. In some of thoseembodiments, anchor 3910 may be at least partially insert molded intoband 3902. Base 3930 may be inserted in band 3902 before band 3902 issolidified. Stem 3920 may be allowed to protrude out of band 3920 toexpose head 3914. In some embodiments, one or more anchors may beattached to band 3902 after band 3902 is solidified.

In some embodiments, band 3902 may be of uniform material properties. Insome embodiments, band 3902 may include regions of different materialproperties. For example, band 3902 may include sections such as 3940 and3950. Section 3940 may be less flexible than section 3950. Section 3940may be less elastic than section 3950. Anchor 3910 may be embedded in orotherwise supported by a section or sections such as 3940. A section orsections such as 3950 may be free from anchors. In embodiments in whichanchor 3910 is embedded in or otherwise supported by a section such as3940, stress concentration near anchor 3910 may be less than inembodiments in which anchor 3910 is embedded or otherwise supported by asection such as 3950. In some embodiments, sections 3940 and 3950 may beformed in different molding stages and bonded together, for example atbond 3960, after at least one has already at least partially solidified.

FIG. 40 shows a preliminary formation stage of illustrative anchor 4000that may be used in conjunction with some embodiments of the invention.Anchor 4000 may be cut or punched from a sheet of material. The sheetmay include metal, rigid polymer, or any other suitable material. Anchor4000 may include one or more stems such as 4020. Stem 4020 may supportanchor head 4014, which may include edge 4012. Holes such as hole 4040may be provided to receive molding material during the formation of aband such as 3902 shown in FIG. 39. In some embodiments of theinvention, hole 4040 may not be present.

FIG. 41 shows a stage of formation of anchor 4000 that is later thanthat shown in FIG. 40. FIG. 41 shows stems such as stem 4020 bent toangle α with respect to edge 4032 of base 4030. Angle α may be 90° orany other suitable angle. Stem 4020 may be positioned at angle β withrespect to edge 4034 of base 4030. Angle β may be 90° or any othersuitable angle. Stem 4020 may curve away from base 4034 in any suitablemanner. Anchor 4000 may include different stems that are positioned atdifferent angles with respect to base 4030. In some embodiments, stem4020 may extend in a curved manner away from base 4030.

FIG. 42 shows a preliminary formation stage of illustrative anchor 4200that may be used in conjunction with some embodiments of the invention.Anchor 4200 may include one or more stems such as stem 4022 coupled tobase 4230 between edges 4232 and 4234 of base 4230. In some embodiments,stem 4022 may be tapered to narrow toward head 4016. Some embodimentsmay include stem 4020 extending from edge 4232 of base 4230. Stem 4020may become more narrow toward head 4014. Edge 4012 may be present onhead 4014 to prevent anchor 4200 from withdrawing from tissue. In someembodiments, edge 4012 may be continuous around the perimeter of stem4020. At a later stage of formation, one or more of stems 4020 and 4022may be repositioned at an angle with respect to face 4236 of base 4230.Holes such as 4240 may be used to receive material during an insertmolding process.

FIG. 43 shows anchor 4300 embedded in material 4302 that may be part ofa band such as band 3902 shown in FIG. 39. Base 4330 may be molded intomaterial 4302. Material 4302 may be present in holes such as 4340 inbase 4330. One or more stems such as stem 4320 may protrude throughmaterial 4302 and support anchor head 4314 that may be used to engagebiological tissue.

FIG. 44 shows illustrative anchor 4410 that may be used in conjunctionwith some embodiments of the invention. Anchor 4410 may be insert moldedinto a portion of band 4402 (shown in part). Anchor 4410 may includeanchor head 4414 joined to stem 4420. Stem 4420 may extend away fromcentral axis C of band 4402 in any suitable direction. In someembodiments, stem 4420 may be curved. Stem 4420 may be joined to base4430 which may have one or more holes such as 4440 to receive materialduring a molding process. Stem 4420 may be joined to face 4434 of base4430.

FIG. 45 shows illustrative anchor 4510 that may be used in conjunctionwith some embodiments of the invention. Anchor 4510 may include stem4520, which may extend from edge 4532 of base 4530. Stem 4520 may bepositioned at angle γ with respect to face 4533 of base 4530. Angle γmay be any suitable angle. Stem 4520 may be positioned at angle δ withrespect to edge 4536 of base 4530. Angle δ may be any suitable angle.

Base 4530 may have one or more holes such as hole 4540 for receivingmaterial during a molding process. FIG. 46 shows anchor 4510 at leastpartially embedded in band 4602 (shown in part). Base 4530 may beencased in band 4602. Stem 4520 may extend from edge 4532 of base 4530to anchor head 4514 outside band 4602. FIG. 47 shows a larger portion ofband 4602 than that shown in FIG. 46. Band 4602 may house numerousanchors such as anchor 4510, each including one or more anchor headssuch as 4514 joined to a stem such as stem 4520 extending away fromcentral axis C in radial direction R. Band 4602 may expand away fromaxis C in direction R. Band 4602 may contract toward axis C in directionI.

FIG. 48 shows illustrative anchor 4810 that may be used in conjunctionwith some embodiments of the invention. Anchor 4810 may include one ormore stems such as stem 4820. Stem 4820 may be joined to anchor head4814. Stem 4820 may be coupled to base 4830. Stem 4820 may extendradially away from central axis C. Stem 4820 may extend away from base4830 in any suitable direction. Stem 4820 may curve away from base 4830in any suitable direction or directions. Base 4830 may be coupled toradially outer face 4804 of band 4802 (shown in part). Holes such ashole 4840 may receive a boss or stud such as boss 4860 extending awayfrom face 4804. Boss 4860 may be terminated in a knob to secure base4830 to face 4804. Any suitable fastener may be used to fasten boss 4860to base 4830.

FIG. 49 shows apparatus 3900 (shown also in FIG. 39 ff) positioned inlumen 2022 of a biological passageway having walls 2028 using balloon4902. Numerous anchors such as anchor 3910 may be present for engagingwall 2028. For the sake of clarity, only two anchors are shown.

FIG. 50 shows apparatus 5000, which may be similar to apparatus 3900, ina stage of deployment later than that shown in FIG. 50 in connectionwith apparatus 3900. Apparatus 5000 may include one or more anchors suchas anchor 5010. Anchor 5010 may include stem 5020 that may pass throughwall 2028 into body cavity 2030. Anchor 5010 may include anchor head5014. Anchor 5010 may include one or more barbs such as barb 5015. Insome embodiments, barb 5015 may springingly rotate about an end joinedto anchor head 5014. In some of those embodiments, barb 5015 may retracttoward stem 5020 as head 5014 penetrates wall 2028. Barb 5015 may springaway from stem 5020 after a free end of barb 5015 clears outer surface2029 of wall 2028. In some embodiments, apparatus 5000 may include anysuitable anchor, including any of the anchors described herein.

FIG. 51 shows apparatus 5100 that may be used to reduce the diameter ofa portion of a biological passage. Band 5102 may be expandable away fromcentral axis C in radial direction R to engage anchors such as anchor5110 in the inner wall of the passage. Anchor 5110 may extend away fromband 5102 in a direction generally the same as direction D.

Anchor 5510 may include one or more primary barbs such as primary barb5112 extending from tip 5114 of anchor 5510. Anchor 5510 may include oneor more secondary barbs such as secondary barb 5113 joined to anchor5110 at a position away from tip 5114. A barb may extend from anchor5110 in any direction. A barb may extend from a portion of anchor 5110that faces generally toward band 5102 (as does barb 5112). A barb mayextend from a portion of anchor 5110 that faces generally away from band5102 (as does barb 5113). An anchor may include barbs facing in morethan one direction. Anchor 5120 is an illustrative example of an anchorthat includes two primary barbs, 5115 and 5117, joined to barb tip 5116.

Apparatus 5100 may be rotated in direction D to cause anchor 5110 topenetrate into the wall. Apparatus 5100 may be rotated in the directionopposite D to engage a barb in the wall tissue. A barb or barbs may helpsecure apparatus 5100 to the inner wall of the biological passage. Afterband 5102 is expanded to engage anchors in the inner wall, band 5102 mayautomatically contract toward axis C and may draw the inner wall inwardin direction I. The diameter of the biological passage may be reduced.

FIG. 52 shows anchors 5110 and 5120 extending away from band 5102. (Someof the anchors shown in FIG. 51 are not shown in FIG. 52 for the sake ofclarity.) FIG. 52 shows that in some embodiments, one or more of barbs5112, 5113, 5115, and 5117 may extend away from a plane defined by band5102. In some embodiments, one or more barbs may be contained in anaxial plane of apparatus 5100.

FIGS. 53-56 illustrate a feature of some embodiments of the invention inwhich at least a portion of an anchor may be projected through anaperture in a band to engage tissue of a biological passage wall. Theanchor portion may then be retracted back toward the band to secure thetissue. FIG. 53 shows a portion of band 5302 in a neutral statepositioned in lumen 2022 near biological passage wall 2028. Radiallyinner edge of band 5302 may be at a distance R1 from central axis C.Band 5302 may have neutral state radial thickness L₁. Anchor 5310 may becoupled to band 5302. Anchor 5310 may be insert molded into band 5302.Anchor 5310 may have one or more holes such as hole 5340 in base 5330 toreceive material during a molding process. Stem 5320 may extend awayfrom base 5330 in radial direction R. Recess 5380, which may includeaperture 5382 may be present in band 5302 near anchor head 5314. In someembodiments, in the neutral state a portion of head 5314, which mayinclude tip 5316, may be present in recess 5380. In some embodiments, inthe neutral state recess 5380 may extend in circumferential directions Pand Q no farther than does trailing edge 5312 of head 5314. In anexpanded state, recess 5380 may expand in directions P and Q to allowhead 5314 to project out of band 5302 as the thickness of band 5302 isreduced.

FIG. 54 shows recess 5380 in band 5302. Head 5314, including tip 5316,is partially exposed through aperture 5382. Portions of head 5314 thatare not exposed through aperture 5382 are shown using broken lines. Whenband 5302 is expanded radially away from axis C, edges 5384 and 5386 ofaperture 5382 may be pulled away from tip 5316 in directions P and Q,respectfully, to allow head 5314 to emerge from band 5302.

Although anchor 5310 is illustrated as a “flat” anchor such as anchor4410 shown in FIG. 44, some embodiments of the invention in which ananchor may project through a band aperture may include one or moreanchors of different types, including one or more the anchors describedherein. The shapes and sizes of recess 5380 and aperture 5382 may bechosen to allow an anchor to emerge from band 5302. The shapes and sizesof recess 5380 and aperture 5382 may be chosen to allow an anchor stemto at least partially retract back into band 5302.

FIG. 55 shows band 5302 in an expanded state. Inner radial edge 5304 ispositioned at distance R₂, which may be greater than distance R₁ (shownin FIG. 53), from central axis C. The radial thickness of band 5302 inthe expanded state is L₂, which may be less than thickness L₁ (shown inFIG. 53). Recess 5380 in the expanded state may have increased (relativeto the neutral state) in circumferential directions P and Q (edge 5384in direction P and edge 5386 in direction Q, e.g.) and may havedecreased in radial thickness. Anchor 5310, which may include materialthat is more rigid than band 5302 may not be deformed as much as band5302 during the expansion of band 5302. Stem 5320 may project out ofrecess 5380 through aperture 5382. Head 5314 may engage tissue of wall2028.

FIG. 56 shows band 5302 in a retracted state. In the retracted state,band 5302 may not be fully retracted to the neutral state shown in FIG.53 because outward radial forces from wall 2028 may act on band 5302after anchor 5310 engages tissue of wall 2028. In the retracted state,inner radial edge 5304 of band 5302 may be positioned at distance R₃from central axis C. R₃ may be greater than R₁ (shown in FIG. 53). R₃may be less than R₂ (shown in FIG. 55). In the retracted state, band5302 may have radial thickness L₃. L₃ may be less than L₁ (shown in FIG.35). L₃ may be greater than L₂ (shown in FIG. 55). Stem 5320 may havepartially retracted behind outer radial edge 5306 of band 5302 drawingedge 5312 of head 5314 toward outer radial edge 5306 and trapping orpinching tissue of wall 2028 in area 5308. Aperture 5382 may havecontracted toward stem 5320. (Edges 5384 and 5386 of recess 5380 mayhave migrated in directions Q and P, respectively, during retraction ofband 5302.) Wall 2028 may be closer to central axis C when band 5302 issecured to wall 2028 and is retracted than before anchor 5310 engagedwall 2028 (as shown in FIG. 53, for example).

FIGS. 57-58 show apparatus 5700 positioned in distal esophagus 23 aboveLES 26. Apparatus 5700, which may include band 5702 and one or moreanchors such as anchor 5710, may have any suitable features for engagingdistal esophagus 23 and reducing the diameter of distal esophagus 23,LES 26, or both. Apparatus 5700 may include one or more of the bands,anchors, and other apparatus described herein.

FIG. 57 shows band 5702 in an expanded state. Anchor heads such as head5714 may extend away from central region 5722 of apparatus 5700. Head5714 may extend all the way through the wall of distal esophagus 23.Opening 5780 of relaxed LES 26 has approximate diameter D₁.

FIG. 58 shows band 5702 in a retracted state. Portions of distalesophagus 23, such as portion 5850, may be drawn toward central region5722 of apparatus 5700. Some portions of distal esophagus 23, such asportion 5860, may not be drawn toward central region 5722. Some portionsof distal esophagus 23, such as portion 5860, may be drawn towardcentral region 5722, but not to the extent that portions such as 5850are drawn toward region 5722. When band 5702 is in the retracted state,opening 5780 of relaxed LES 26 may be reduced. When band 5702 isretracted, opening 5780 may have approximate diameter D₂, which may beless than approximate diameter D₁ (shown in FIG. 57). Broken line 5870shows the approximate size of opening 5780 when band 5702 is in theexpanded state (as shown in FIG. 57).

FIGS. 59-61 show features of some embodiments of the invention that mayinclude a deposit of substance on an apparatus that may be used toreduce the diameter of a biological passage. The substance may have atherapeutic effect on the biological passage. The substance may helpseal the apparatus to the passage. In some embodiments, the substancemay be a foam. In some embodiments, the substance may be a gel. In someembodiments, the substance may include a drug. In some embodiments, thesubstance may include an adhesive.

FIG. 59 shows apparatus 5900 positioned in biological passage havingwall 2028. Apparatus 5900 may include band 5902 and one or more anchorssuch as 5910. Apparatus 5900 may have any suitable features for engagingwall 2028. Apparatus 5900 may have any suitable features for reducingthe diameter of the biological passage. Apparatus 5900 may include oneor more of the bands, anchors, and other apparatus described herein.

FIG. 59 shows band 5902 in an expanded state. Anchors such as anchor5910 may extend through wall 2028. Substance 5950 may be present on band5902. In some embodiments, substance 5950 may be disposed on innersurface 5904 of band 5902. In some embodiments, substance 5950 may bepresent in pores that may be present in band 5902. In some embodiments,substance 5950 may be present in pores that may be present in one ormore anchors such as anchor 5910. Substance 5950 present in pores or onthe surface of apparatus 5900 may elute from the apparatus. In someembodiments, substance 5950 may be soluble. In some embodiments,substance 5950 may gradually migrate to portions of the passageincluding wall 2028.

FIG. 60 shows substance 5950 disposed on inner surface 5904 of band 5902near anchor 5910 protruding through wall 2028.

FIG. 61 shows band 5902 in a retracted state. Portions of wall 2028 suchas portion 6030 may be drawn toward the central region of lumen 2022 ofthe biological passage. Portions of wall 2028 such as portion 6040 maybe drawn toward the central region of lumen 2022, but may not be drawnas far as portions such as portion 6030. Some portions of wall 2028 maynot be drawn toward the central region of lumen 2022. Substance 5950 maybe squeezed toward central region of lumen 2022. Substance 5950 may bedeposited on portions of wall 2028 by apparatus 5900.

FIGS. 62-65 show illustrative examples of features that may be presentin some embodiments of the invention that may be used to line a portionof a biological passage. FIG. 62 shows liner 6200 that may be disposedin lumen 27 of esophagus 22 adjacent LES 26. (In some embodiments of theinvention, liner 6200 may be prophylactically disposed in a healthyesophagus.) Liner 6200 may include inert material for protecting tissueof LES 26 from irritation, degradation, or any other effects ofchemicals or biological materials that may be present in esophagus 22.Liner 6200 may include flexible material. Liner 6200 may include elasticmaterial. In some embodiments of the invention, liner 6200 may besecured to wall 25 of esophagus 22 by anchors such as anchor 6210.

In some embodiments, liner 6200 may be held in place by one or moreballoon-expandable frames. In some of those embodiments, the frame orframes may be plastically deformed. The frame or frames may retain ashape established by the balloon when the balloon is dilated.

In some embodiments, liner 6200 may be held in place by a self-expandingframe (not shown). In some of those embodiments, the frame may includeelastic material. The frame may be compressed for insertion in esophagus22 and may expand in lumen 27 sufficiently to conform to wall 25. Insome embodiments, liner 6200 may not include an anchor. In someembodiments, liner 6200 may be held in place using any suitablestructure or structures, including any band or bands, anchor or anchors,or any combination thereof described herein. In some embodiments, liner6200 may be deployed using any suitable device or devices, including anysuitable device or device described herein.

FIG. 63 shows liner 6300 positioned adjacent LES 26. Liner 6300 mayinclude end portion 6310. Liner 6300 may include end portion 6320. Liner6300 may include medial portion 6330. Medial portion 6330 may bepositioned at the narrowest constriction of lumen 27.

Frame 6340 may be present near end portion 6310 to conform end portion6310 to wall 25. Frame 6350 may be present near end portion 6320 toconform end portion 6320 to wall 25. Medial portion 6330 may not have acorresponding frame to allow medial portion 6330 to closely contour wall25. In some embodiments, a frame may be present near medial portion 6330to secure medial portion 6330 to wall 25. Frames may be positionedinternal to liner 6300 or external to liner 6300. In some embodimentsnumerous frames may be present to conform liner 6300 to wall 25. In someembodiments, liner 6300 may be held in place using any suitablestructure or structures, including any band or bands, anchor or anchors,or any combination thereof described herein. In some embodiments, liner6300 may be deployed using any suitable device or devices, including anysuitable device or device described herein.

FIG. 64 shows illustrative pre-shaped liner 6400. Pre-shaped liner 6400may be shaped outside of a biological passage and inserted into thepassage. In some embodiments, liner 6400 may be shaped in accordancewith a known profile of the biological passage in which line 6400 willbe deployed. Liner 6400 may be shaped in accordance with passage profiledata that may be collected from the passage (for example, by directmeasurement or by medical imaging). Liner 6400 may include any suitableinert material that is formable. In some embodiments, liner 6400 mayinclude a thermoplastic material. In some embodiments, line 6400 may bemolded. In some embodiments, liner 6400 may be held in place using anysuitable structure or structures, including any band or bands, anchor oranchors, or any combination thereof described herein.

FIG. 65 shows apparatus 6500 that may include liner 6520, which mayinclude inert material. Apparatus 6500 may include inner liner 6540,which may include inert material. Apparatus 6500 may be positioned inthe lumen of a biological passage to protect a portion of the passagefrom harmful materials. In some embodiments, apparatus 6500 may includeframe 6502. Frame 6502 may be positioned between inner liner 6540 andouter liner 6520. Anchors such as anchor 6510, which may include barb6512, may be present on frame 6502 to attach apparatus 6500 to thebiological passage wall. Anchor 6510 may include inert material. Someembodiments may not include an anchor.

Frame 6502 may include inert material. In some embodiments, frame 6502may be self-expanding. In those embodiments, frame 6502 may includeelastic material that can be compressed to insert frame 6502 in abiological passage. After positioning frame 6502 in the passage, frame6502 may expand to cause liner 6520 to contact the passage wall. In someembodiments, frame 6502 may include ductile or plastically deformingmaterial. In those embodiments, frame 6502 may be inserted in a state inwhich frame 6502 is of smaller diameter than the passage. Frame 6502 maythen be expanded by dilating a balloon in bore 6550. After expansion,frame 6502 may remain in an expanded state.

In some embodiments, apparatus 6500 may be held in place using anysuitable structure or structures, including any band or bands, anchor oranchors, or any combination thereof described herein. In someembodiments, apparatus 6500 may be deployed using any suitable device ordevices, including any suitable device or device described herein.

FIGS. 66-69 show illustrative examples of features that may be presentin some embodiments of the invention and that may regulate the flow ofmatter through a biological passage. In some embodiments, these featuresmay promote chemical or biochemical reactions. FIG. 66 shows apparatus6600 that may be deployed in a biological passage having lumen 2022 andwall 2028. Wall 2028 and lumen 2022 are shown in sectional view.

Apparatus 6600 may include band 6602 that may be secured against wall2028. One or more fingers such as finger 6620 may extend from band 6602into lumen 2022. Finger 6620 may be flexible. In some embodiments,finger 6620 may include one or more fibers. In some embodiments, finger6620 may include one or more surface area enhancing features such asfeature 6622.

Feature 6622 may be a fold, a pleat, a groove, a bend, a projection, aprotuberance, or any other suitable type of surface area feature. Insome embodiments, finger 6620 may include more than one type of surfacearea enhancing feature. In some embodiments, apparatus 6600 may includemore than one type of finger. In some embodiments, fingers may beclosely spaced with respect to each other. In some embodiments, spacemay be present between fingers.

In some embodiments, one or more fingers may extend to central region6624 of apparatus 6600. In some embodiments, one or more fingers mayextend only into marginal region 6626 of apparatus 6600. In someembodiments, apparatus 6600 may include short fingers and long fingers.In some embodiments, apparatus 6600 may include fingers that are curved.In some of those embodiments, the fingers may curve in the distaldirection, in the proximal direction, or in a direction that isnon-radial (with respect to axis C).

In some embodiments, apparatus 6600 may be held in place using anysuitable structure or structures, including any band or bands, anchor oranchors, or any combination thereof described herein. In someembodiments, apparatus 6600 may be deployed using any suitable device ordevices, including any suitable device or device described herein.

FIG. 67 shows finger 6620 and a finger opposite finger 6620 on band6602. In some embodiments, finger 6620 may bend from the rest positionshown (approximately perpendicular to wall 2028) in direction B₁. Insome embodiments, finger 6620 may bend in direction B₂. Broken linesshow different positions that may be occupied by finger 6620 and theopposite finger as the fingers flex. The flexibility of finger 6620 maybe preselected to regulate the amount of flex that will occur inresponse to a given force. In some embodiments, finger 6620 may have arest position that is at an angle to wall 2028. In some of thoseembodiments, numerous fingers may have a rest position that is at anangle to wall 2028 to provide a directional bias to material that mayflow through lumen 2022.

FIG. 68 shows finger 6800 that may be included in an apparatus such as6600. Finger 6800 may have tip 6820 which may project into lumen 2022.In some embodiments, finger 6800 may taper to a narrow terminus or conethat may project into lumen 2022. Finger 6800 may include one or moresecondary members such as member 6830. In some embodiments member 6830may extend away from finger 6800 to a greater extent than that shown inFIG. 68. Member 6830 may include one or more surfaces such as surface6840.

FIG. 69 shows finger 6900 that may be included in an apparatus such as6600. Finger 6900 may have tip 6920 which may project toward lumen 2022.In some embodiments, finger 6900 may taper to a narrow terminus or conethat may project into lumen 2022. Finger 6900 may include one or moresecondary members such as member 6930. In some embodiments, member 6930may extend away from finger 6900 to a greater extent than that shown inFIG. 69. Member 6930 may include one or more surfaces such as surface6940.

It will be appreciated by one skilled in the art that any featureillustrated with or without a reference numeral in any of the FIGS.herein, including, but not limited to, any anchor, portion of an anchor,band, portion of a band, liner, portion of a liner, finger, and/orportion of a finger, if present in an embodiment of the invention, mayinclude any suitable attribute or suitable combination of attributesshown (with or without a reference numeral) or described in connectionwith any of the embodiments herein.

Thus it is seen that improved apparatus and methods for reducing thediameter of a portion of a biological passage have been provided.Apparatus and methods for lining a portion of a biological passage havebeen provided. Apparatus and methods deploying a baffle in a portion ofa biological passage have been provided. One skilled in the art willappreciate that the present invention can be practiced by other than thedescribed embodiments, which are presented for purposes of illustrationand not of limitation, and the present invention is limited only by theclaims which follow.

1. An apparatus for reducing the diameter of a portion of a biologicalpassage, said passage having a wall, said apparatus comprising: apolymeric body having a bore, said bore defining a central axis, atleast a portion of said body configured to move from a first position toa second position, said second position at a greater distance from saidaxis than said first position, said portion having an outer peripheralsurface; and a metal anchor coupled to said portion, said anchor havinga tip; wherein: said tip moves away from said outer peripheral surfacewhen said portion moves from said first to said second position; andsaid anchor is configured to pull said wall toward said axis when saidportion moves from said second position toward said first position.